Trials can reduce timelines, cut costs and more easily produce FDA-acceptable data with biomarkers and clinical outcomes assessments (COA) the agency has already qualified under its drug development tools (DDT) program. And with 118 new tools in the pipeline, the program is gaining momentum. Read More
Shrinking awareness of and growing distrust for clinical research could make it challenging for trials to recruit and retain study participants in the near term, according to preliminary results from an ongoing study by the Center for Information and Study on Clinical Research Participation (CISCRP). Read More
The evolution of digital technologies used in clinical trials will require a shift in the nature of the workforce, with new skills needed and new roles created. Read More
Overly compartmentalized approaches to testing new data management solutions is one of the key obstacles to widespread adoption within an organization, research by the Tufts University Center for the Study of Drug Development (CSDD) and Saama Technologies indicates. Read More
Data management and loss prevention is important to any business, but it’s particularly critical to clinical research, which relies on the ability to collect, retrieve and analyze accurate, reliable data. Read More
Quality management is a concept familiar to drug- and devicemakers because of the FDA’s regulations on the subject, but there are no parallel rules for clinical trials. That will change when the revised version of the International Council on Harmonization’s (ICH) E8(R1) guideline, General Requirements for Clinical Studies, is finalized later this year and adopted by regulators. Read More
Interest in making greater use of real-world data (RWD) is growing among clinical researchers, regulators and healthcare providers alike, but effective collection and analysis of RWD on a large scale will require a collaborative “ecosystem” in which data collection is standardized for easier analysis. Read More
Despite the increasing complexity of clinical trials and the availability of portable technology to help researchers access key protocol information on the fly, investigators and staff at clinical sites continue to show a marked tendency toward the old school, seeming to prefer to rely on printouts and workstation desktops to access protocol information. Read More
As clinical trials grow more complex and technology offers more ways to acquire and process the data generated during studies, researchers face a growing tension between providing data for evaluation quickly — often with goals of near-real-time — and ensuring that it is accurate and free from anomalies. Read More
Addressing risks associated with the COVID-19 pandemic while embracing new and more accessible approaches to keep clinical trials running may have uncovered the secret to improving the pharma industry’s return on investment (ROI) in R&D. Read More